Application 207835

Type: ANDA
Sponsor: UNICHEM LABS LTD

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	RIZATRIPTAN BENZOATE	RIZATRIPTAN BENZOATE	TABLET, ORALLY DISINTEGRATING;ORAL	EQ 5MG BASE	No	No
002	RIZATRIPTAN BENZOATE	RIZATRIPTAN BENZOATE	TABLET, ORALLY DISINTEGRATING;ORAL	EQ 10MG BASE	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A207835-001	RIZATRIPTAN BENZOATE	RIZATRIPTAN BENZOATE	EQ 5MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL			2017-03-07
A207835-002	RIZATRIPTAN BENZOATE	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL			2017-03-07

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A207835-001	RIZATRIPTAN BENZOATE	EQ 5MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL		2017-03-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207835-002	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL		2017-03-07	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207835-001	RIZATRIPTAN BENZOATE	EQ 5MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL		2017-03-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207835-002	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL		2017-03-07	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207835-001	RIZATRIPTAN BENZOATE	EQ 5MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL		2017-03-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207835-002	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL		2017-03-07	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207835-001	RIZATRIPTAN BENZOATE	EQ 5MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL		2017-03-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207835-002	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL		2017-03-07	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207835-001	RIZATRIPTAN BENZOATE	EQ 5MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL		2017-03-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207835-002	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL		2017-03-07	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207835-001	RIZATRIPTAN BENZOATE	EQ 5MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL		2017-03-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207835-002	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL		2017-03-07	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207835-001	RIZATRIPTAN BENZOATE	EQ 5MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL		2017-03-07	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207835-002	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL		2017-03-07	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207835-001	RIZATRIPTAN BENZOATE	EQ 5MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL		2017-03-07	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207835-002	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL		2017-03-07	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207835-001	RIZATRIPTAN BENZOATE	EQ 5MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL		2017-03-07	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207835-002	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL		2017-03-07	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207835-001	RIZATRIPTAN BENZOATE	EQ 5MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL		2017-03-07	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207835-002	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL		2017-03-07	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207835-001	RIZATRIPTAN BENZOATE	EQ 5MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL		2017-03-07	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207835-002	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL		2017-03-07	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207835-001	RIZATRIPTAN BENZOATE	EQ 5MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL		2017-03-07	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207835-002	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL		2017-03-07	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207835-001	RIZATRIPTAN BENZOATE	EQ 5MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL		2017-03-07	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207835-002	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL		2017-03-07	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207835-001	RIZATRIPTAN BENZOATE	EQ 5MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL		2017-03-07	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A207835-002	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL		2017-03-07	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207835-001	RIZATRIPTAN BENZOATE	EQ 5MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2017-03-07	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207835-002	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2017-03-07	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A207835-001	RIZATRIPTAN BENZOATE	EQ 5MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2017-03-07	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A207835-002	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2017-03-07	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A207835-001	RIZATRIPTAN BENZOATE	EQ 5MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2017-03-07	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A207835-002	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2017-03-07	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A207835-001	RIZATRIPTAN BENZOATE	EQ 5MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2017-03-07	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A207835-002	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2017-03-07	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A207835-001	RIZATRIPTAN BENZOATE	EQ 5MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2017-03-07	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A207835-002	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2017-03-07	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A207835-001	RIZATRIPTAN BENZOATE	EQ 5MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2017-03-07	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A207835-002	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2017-03-07	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 44 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207835-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207835-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A207835-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A207835-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A207835-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A207835-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A207835-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A207835-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A207835-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A207835-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A207835-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A207835-002	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A207835-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A207835-002	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A207835-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A207835-002	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A207835-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A207835-002	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A207835-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A207835-002	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A207835-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A207835-002	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A207835-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A207835-002	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A207835-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A207835-002	AB	1	`ea99ee380514…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A207835-001	AB	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A207835-002	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A207835-001	AB	1	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A207835-002	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A207835-001	AB	1	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A207835-002	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A207835-001	AB	1	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A207835-002	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A207835-001	AB	1	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A207835-002	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A207835-001	AB	1	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A207835-002	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A207835-001	AB	1	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A207835-002	AB	1	`f41ea6bd6efb…`

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Rizatriptan Benzoate	RIZATRIPTAN BENZOATE	Unichem Pharmaceuticals (USA), Inc.	3cdeccf6-36dd-4a9e-9687-2f7cce47af5f	2020-04-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207835 application number: ANDA207835 ndc (product): 29300-269 ndc (product): 29300-268
Rizatriptan Benzoate	RIZATRIPTAN BENZOATE	Proficient Rx LP	f5520526-1cc5-489f-b142-92f92fec77d3	2020-02-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207835 application number: ANDA207835 ndc (product): 71205-398

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 7 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
29300-268	Rizatriptan Benzoate	Rizatriptan Benzoate	Unichem Pharmaceuticals (USA), Inc.	ANDA	Current
29300-268	Rizatriptan Benzoate	Rizatriptan Benzoate	Unichem Pharmaceuticals (USA), Inc.	ANDA	Current
29300-268	Rizatriptan Benzoate	Rizatriptan Benzoate	Unichem Pharmaceuticals (USA), Inc.	ANDA	Current
29300-269	Rizatriptan Benzoate	Rizatriptan Benzoate	Unichem Pharmaceuticals (USA), Inc.	ANDA	Current
29300-269	Rizatriptan Benzoate	Rizatriptan Benzoate	Unichem Pharmaceuticals (USA), Inc.	ANDA	Current
29300-269	Rizatriptan Benzoate	Rizatriptan Benzoate	Unichem Pharmaceuticals (USA), Inc.	ANDA	Current
71205-398	Rizatriptan Benzoate	Rizatriptan Benzoate	Proficient Rx LP	ANDA	Current